- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07626346
Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-guided Pericapsular Nerve Group Block( PENG)
The Analgesic Efficacy of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-guided Pericapsular Nerve Group Block( PENG) in Patients Undergoing Laparoscopic Shoulder Surgeries: A Randomized Controlled Trial
Patients are greatly concerned about pain that occurs shortly after shoulder surgeries. Most patients experience significant pain after shoulder surgery, with almost half reporting severe pain immediately after. Since shoulder surgeries are usually done as outpatient or one day procedures, good pain control after surgery is important for quick recovery and rehab for patient's overall recovery. Interscalene nerve blocks provide the best pain relief for shoulder surgery patients. They reduce pain for at least 8 hours and decrease the need for opioids for 8 to 12 hours after surgery. It anesthetizes most of the brachial plexus, except the ulnar nerve (C8-T1). It is useful for surgeries on the distal clavicle, shoulder, and proximal humorous .However, interscalene blocks also raise concerns about temporary and potential long-term problems with breathing, especially paralysis of the diaphragm and phrenic nerve. By targeting nerve roots in the neck rather than peripheral nerves, interscalene blocks also carry a higher risk of nerve damage.The pericapsular nerve group block has been effectively used in hip surgeries as in hip arthroplasty and it is one of the best regional anesthesia regarding many other hip operations. Recently PENG block has also shown to have strong analgesic effect on shoulder surgeries.
Dexmedetomidine (DEX) is a highly selective Alpha-2 adrenergic agonist. It has sedative and analgesic properties that thought to be due to binding to both presynaptic and postsynaptic alpha-2 adrenoreceptors and inhibiting the release of norepinephrine, as a result, it terminates the propagation of pain signals and inhibits the sympathetic activity decreasing heart rate and blood pressure.
The aim of our study is to compare the effect of adding dexmedetomidine to bupivacaine in ultrasound-guided Pericapsular nerve group block (PENG) with bupivacaine alone and determine its effect on duration of analgesia and post-operative opioid consumption.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Patients meeting the inclusion criteria will be randomly assigned to receive either:
Group A: PENG block with bupivacaine only (number of patients: 42) Group B: PENG block with bupivacaine and dexmedetomidine (number of patients: 42)
Preoperative assessment:
Preoperative assessment of all patients undergoing elective laparoscopic shoulder surgical procedures under general anaesthesia comprised of history taking, clinical examination, laboratory testing (complete blood count, kidney function tests, and liver function tests), electrocardiogram, and chest X-ray. The study protocol will be explained to the patients, and their consent will be obtained.
The visual analogue score (VAS) will be explained to all patient in details as it will be used as a measurement tool for assessment of postoperative pain
Operating Room preparation & Equipment:
The ultrasound used will be Siemens ACUSON X300 Ultrasound System, the scanning probe is a linear probe 8-14 MHZ. A 50-mm block needle 22 gauge will be used. (SonoPlex Stim Cannula, Germany).
All blocks will be given by one researcher using 20 ml of drug 0.25% bupivacaine either alone or with dexmedetomedine.
After arrival to the anesthetic room, an 18-gauge intravenous cannula will be placed at the forearm contralateral to the operated arm, standard monitoring will be used (non-invasive arterial blood pressure, ECG, pulse oximetry).
Premedication will be given intravenously in the form of 0.03 mg/kg midazolam, ranitidine 2.0 mg/kg IV and metoclopramide 0.1 mg/kg IV).
Patients will be randomly assigned to either the intervention group will receive PENG block with bupivacaine 0.25% and dexmedetomidine 1 µg/kg (maximum dose of 100 µg) diluted in normal saline (total volume of 20 mL) or control group will receive PENG block with bupivacaine 0.25% (20 mL) diluted in normal saline.
PENG block:
The patient will be asked to lie supine with his or her arm then positioned in a 45-degree abducted external rotation. A linear ultrasound probe was placed lengthwise between the coracoid and humeral head. Once the humeral head, subscapular muscle tendon, and deltoid muscle were identified, a 50-mm needle will be inserted using the "in plane" technique. The needle then will be advanced through the deltoid muscle and towards the subscapularis tendon, until a bony-like hard tissue is felt, preventing further advancement of the needle. The needle is placed now between the deltoid muscle and subscapularis tendon in which injection will be done.
Thirty minutes after performing the block patients will receive general anaesthesia. Anaesthesia will be induced with propofol (2 mg/kg), fentanyl (2 μg/kg) and atracurium (0.5 mg/kg). The GA will be maintained by isoflurane (1.2 %) and Atracurium (0.1 mg/kg/20 min). the surgery will then be started and intraoperative vital signs as heart rate, MAP (mean arterial blood pressure) will be monitored all throughout. If at anytime during the operation hypertension and tachycardia were observed, fentanyl 50 mic will be given as an intraoperative rescue analgesia.
After skin closure, muscle relaxation will be reversed using Neostigmine (0.04mg/kg) and Atropine (0.01mg/kg) after the return of spontaneous breathing. After extubation patients will be transferred to the post-anesthesia care unit (PACU) for 60 min for complete recovery and monitoring.
If at any point hypotension occurred (defined as a decrease in mean arterial pressure > 25% from the baseline value or systolic arterial pressure of 100 mmHg), it will be treated with 5 mg of IV bolus ephedrine, which will be repeated every 3 min until the hypotension resolved. Bradycardia (defined as an HR of 40 beats/min) will be treated with intravenous atropine (0.5 mg).
Postoperative vital signs (heart rate and MAP) and VAS for pain will be recorded at 0, 2, 6, 12, 24 hours and if VAS ≥3 or when the patient asks for analgesia, morphine IV (0.1mg/kg) will be given (rescue analgesia) targeting VAS ≤ 2 while the maximum allowed dose of morphine is 30 mg / 24 hours. The time to first call for analgesia is defined as (the time interval from tracheal extubation to first dose of morphine administration) will be recorded. The patient will receive paracetamol (1gm/8hrs IV) as a regular analgesia as soon as he is discharged from the recovery and admitted to the post-operative ward. The total amount of morphine in the first postoperative 24 hours will be calculated in both groups If the patient requires more than two doses of rescue analgesia in the first hour following surgery, the block will be deemed to have failed.
-Post operative haemodynamic will be assessed (heart rate and MAP at the same time point).
Incidence of adverse effects, such as hypotension, bradycardia, and sedation.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Ahmed nabih, lecturer
- Numero di telefono: +201002773488
- Email: nabihomar100@yahoo.com
Backup dei contatti dello studio
- Nome: Mohammed Belita, lecturer
- Numero di telefono: +201001007485
- Email: mbeleta75@gmail.com
Luoghi di studio
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Cairo, Egitto
- Kasr Alainy
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Contatto:
- Ahmed nabih, lecturer
- Numero di telefono: +201002773488
- Email: nabihomar100@yahoo.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Male or female patients aged 18-65 years
- Patients Undergoing laparoscopic shoulder surgeries (shoulder arthroplasties and shoulder endoscopic surgeries )
- American Society of Anesthesiologists (ASA) physical status I-II
Exclusion Criteria:
- Patient refusal.
- hypersensitivity or contraindication to dexmedetomidine
- History of allergy or intolerance to study medications
- Chronic opioid use (>3 months)
- Pregnancy or breastfeeding
- Severe renal or hepatic impairment
- Patient's with coagulopathy disorders
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: PENG block with bupivacaine
ultrasound-guided Pericapsular nerve group block with bupivacaine
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ultrasound-guided Pericapsular nerve group block
|
|
Sperimentale: PENG block with bupivacaine and dexmedetomidine
ultrasound-guided Pericapsular nerve group block with bupivacaine and dexmedetomidine
|
ultrasound-guided Pericapsular nerve group block
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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È ora di salvare l'analgesia
Lasso di tempo: le prime 24 ore dopo l'intervento
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È definito come tempo dall'estubazione fino al tempo al primo requisito analgesico durante le prime 24 ore dopo l'intervento.
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le prime 24 ore dopo l'intervento
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Il consumo totale di oppioidi
Lasso di tempo: le prime 24 ore dopo l'intervento
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Il consumo totale di oppioidi in MG
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le prime 24 ore dopo l'intervento
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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Nasr Abdallah, Professor, anesthesia department , cairo university
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Dolore
- Manifestazioni neurologiche
- Malattie muscoloscheletriche
- Malattie articolari
- Artralgia
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Dolore alla spalla
- Procedure chirurgiche, operative
- Anestesia e analgesia
- Procedure neurochirurgiche
- Anestesia, conduzione
- Anestesia
- Denervazione
- Blocco nervoso
Altri numeri di identificazione dello studio
- MS -493-2023
Informazioni su farmaci e dispositivi, documenti di studio
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